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Home OGTT viable alternative to clinic-based test
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A home oral glucose tolerance test may be able to provide sensitivity and specificity measures that compare favorably with laboratory analysis, according to findings published in Diabetic Medicine.
“In clinical settings where OGTT is the recommended test, for example [gestational diabetes] in pregnancy and cystic fibrosis-related diabetes, poor availability and accessibility of OGTT often leads to low compliance,” Gareth J. Dunseath, PhD, a senior research officer for the Diabetes Research Group at Swansea University in the U.K., and colleagues wrote. “A novel test kit has been developed with the intention that untrained individuals can perform the OGTT conveniently at home providing a convenient alternative to a conventional clinic-based test.”
Dunseath and colleagues tested the home OGTT (SmartSensor Telemed device, Digostics Ltd.) in comparison with laboratory analysis in 100 women (mean age, 35.8 years; mean BMI, 33.9 kg/m2) at the Joint Clinical Research Facility of Swansea University from April 2017 to June 2018. Although the home OGTT was designed to be used by anyone, for this study, the test was performed by trained nurses. Participants had a blood sample taken from their finger after an overnight fast and then drank a mixture containing 75 g glucose. Another blood sample was then taken 2 hours later. Laboratory analysis was performed using venous blood samples that were collected at baseline and at the 2-hour mark.
The results of the home OGTT and laboratory analysis showed “good agreement,” according to the researchers, who noted that there was a “small negative bias” with the home test (–0.18 mmol/mol). Measurements of fasting plasma glucose from the home test had 100% sensitivity and 98.8% specificity when determining glucose intolerance, which was defined as an FPG measure of 6.1 mmol/L or more. These marks compared with 100% sensitivity and 96.1% specificity when using the laboratory analysis. For 2-hour plasma glucose intolerance, which was defined by a measure of 7.8 mmol/L or more, the home test produced 90% sensitivity and 98.7% specificity compared with marks of 100% and 98.6% from the laboratory analysis. The researchers further noted positive predictive values of 94.1% and 94.7% when using FPG and 2-hour plasma glucose in the home test, respectively, compared with marks of 82.4% and 93.3% in the laboratory analysis. Negative predictive values reached 100% and 97.4% for FPG and 2-hour plasma glucose, respectively, using the home test compared with 100% for both measures in laboratory analysis.
“The excellent agreement between the home OGTT device and laboratory analyzers makes it an effective alternative for clinic-based OGTTs, particularly in parts of the world where the use of HbA1c is limited by common clinical conditions,” the researchers wrote. “Because the device does not give glucose values or diagnostic information directly to the user, interpretation of the results remains with the health care provider who can then offer the most appropriate advice or treatment options. The home OGTT device is also easy to use, giving the potential for a significant improvement in compliance with uptake.” – by Phil Neuffer
Disclosures: The study was funded by Digostics Ltd. The authors report no relevant financial disclosures.
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